• Cerapedics

  Led · Debt Financing · Apr 2015

  Cerapedics, led by CEO Glen A. Kashuba and based in Westminster, Colo., develops and commercializes a proprietary biomimetic small peptide (P-15) technology platform. Its core product, i-FACTOR Peptide Enhanced Bone Graft, is a biologic bone that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. The company received Premarket Approval (PMA) from the U.S. Food & Drug Administration for use of i-FACTOR in anterior cervical discectomy and fusion (ACDF) procedures. Cerapedics has also initiated an IDE clinical trial in transforaminal lumbar interbody fusion (TLIF) surgery. The company intends to use new financing to accelerate commercialization and a U.S. lumbar trial for i-FACTOR. Cerapedics is a Westminster, CO-based orthobiologics company developing and commercializing bone graft substitute products for the treatment of orthopedic injuries. The company is focused on a proprietary synthetic small peptide (P-15) technology platform. Its flagship product, i-FACTOR Peptide Enhanced Bone Graft, incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. That mechanism is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. i-FACTOR is an FDA-approved product for Anterior Cervical Discectomy and Fusion (ACDF). The company is led by CEO Glen Kashuba and is pursuing broader commercialization and additional clinical study applications. Cerapedics develops and commercializes a proprietary synthetic small peptide (P-15) technology platform for orthopedic bone grafts. Its lead product, i-FACTOR Peptide Enhanced Bone Graft, incorporates a small peptide as an attachment factor to stimulate natural bone healing. i-FACTOR received FDA approval in November 2015 for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease. The company plans to use new financing to expand commercialization of i-FACTOR and to further develop its P-15 technology for fusion in the lumbar spine. Cerapedics is led by CEO Glen Kashuba and is based in Westminster, Colorado. Recent financing activity reflects ongoing efforts to commercialize its technology and advance product development. Cerapedics develops and commercializes a proprietary synthetic small peptide (P-15) technology platform and the i-FACTOR biologic bone graft, which uses a small peptide as an attachment factor to stimulate bone healing. The company filed a Premarket Approval (PMA) application with the U.S. Food & Drug Administration for i-FACTOR in September 2014. Cerapedics plans to use recent financing to advance i-FACTOR's development and to expand commercialization in markets outside the U.S. The company is led by CEO Glen Kashuba and is based in Westminster, CO. Financially, the company has completed multiple financings, including the current raise and prior venture debt and equity rounds noted in company reports. Cerapedics is an orthobiologics company focused on developing and commercializing a proprietary synthetic small peptide (P-15) technology platform. Its lead product, the i-FACTOR bone graft, incorporates a small peptide as an attachment factor to stimulate the natural bone healing process and is described as the only biologic bone graft that uses a small peptide in this way. The company says the mechanism is designed to support safer and more predictable bone formation at a lower cost compared to commercially available bone growth factors. Cerapedics is using the recent financing to support general business operations and to advance its U.S. regulatory process. The company is privately held and is based in Westminster, Colorado. Glen Kashuba is cited as Cerapedics’ CEO in the announcement.

• GeneSight

  Participated · Debt Financing · May 2014

  Assurex Health offers GeneSight, a treatment-decision-support test powered by CPGx™, its proprietary combinatorial pharmacogenomics technology, which measures multiple genomic variants and weights them together to provide genetically-driven medication information for each patient. The company recently enhanced the GeneSight Psychotropic test to give providers an expanded range of options for treating depression, anxiety, bipolar disorder, PTSD, schizophrenia and other behavioral health conditions. To date more than 14,000 healthcare providers have used GeneSight to help make treatment decisions for over 230,000 patients across the country. Led by President and CEO Virginia C. Drosos, Assurex will use additional funding to continue to increase adoption of GeneSight. The company also serves chronic pain conditions through its treatment decision support offerings. Assurex Health provides healthcare providers with GeneSight, a treatment decision‑support platform that analyzes how a patient’s genetics affect responses to medications for behavioral health and chronic pain. GeneSight evaluates a patient’s cheek swab against over 785,000 genetic–medication permutations and reports on 38 FDA‑approved medications across depression, PTSD, bipolar disorder, schizophrenia and other mental health conditions. Results are delivered in an actionable color‑coded report available 36 hours after Assurex receives a patient sample. The company also offers financial assistance programs for eligible patients. Led by President and CEO Virginia C. Drosos, Assurex is using proceeds from a $30M equity financing to support increased clinical adoption and further development of its GeneSight products. Assurex Health is a Mason, OH–based personalized medicine company that provides clinically-relevant individualized genetic information to help physicians select medications for depression, anxiety, chronic pain, ADHD and other neuropsychiatric disorders. Its core product is the GeneSight® suite, built on proprietary pharmacogenomics technology combined with evidence-based medicine and clinical pharmacology. The company has licensed patented technology from Mayo Clinic and Cincinnati Children’s Hospital Medical Center. Led by CEO James S. Burns, Assurex intends to use the proceeds from its financing to support increasing clinical adoption of its GeneSight products. The company secured a $32M financing comprising a $25M term and revolving credit facility and a $7M equity financing from existing investors.

• SynGen

  Led · Debt Financing · Feb 2014

  SynGen, Inc., based in Sacramento, California, develops instrument systems for harvesting stem and progenitor cells from umbilical cord blood, bone marrow, peripheral blood, and cell culture. Its product suite includes the SynGenX-1000 System as well as SynGenX-Lab and the CellWashPRO devices for stem cell processing. The company will use the latest financing to make first sales of the SynGenX-1000 System to cord blood banks and to continue commercialization of SynGenX-Lab and CellWashPRO. Bay City Capital has been the primary investor, initially putting $5M into a Series A in April 2012 and subsequently providing additional financing. Financing has been provided in the form of convertible notes; the most recent notes increased total investment to $10M. SynGen is led by President and CEO William Gerber. SynGen invents and commercializes automated electromechanical medical devices and single-use sterile plastic cartridge disposables to isolate and capture stem and progenitor cells from peripheral and umbilical cord blood, bone marrow, and adipose tissue. The company has a 510(k)-approved bench-top system for isolating stem cells. Its products are positioned as an enabling platform for diagnostic, research, and clinical processes in regenerative medicine. SynGen says the financing will support the company’s commercialization efforts for its devices. CEO Phil Coelho stated GE Capital provided a credit facility tailored to accommodate the growth phase the company is entering and that SynGen looks forward to a long-term relationship. GE Capital noted its support for commercialization of a device that harvests adult stem cells from blood or bone marrow for clinical use in regenerative medicine. SynGen develops single-use sterile plastic cartridge disposables mated to dedicated, highly automated electromechanical medical devices to isolate and capture stem and progenitor cells from peripheral and umbilical cord blood, bone marrow, and adipose tissue. Its products address diagnostic, research, and clinical applications. The company's lead product is the SynGen-1000 platform, which it intends to commercialize initially for cord blood banks. SynGen completed a $5M Series A financing to accelerate commercialization of the SynGen-1000. The company expects to file for 510(k) clearance with the FDA and to achieve CE marking for the SynGen-1000 in the near future. Subsequent designs will target emerging markets including stem cell research centers, hospitals practicing cell therapy in surgical suites, and stem cell clinical trials. The company is led by president and CEO Phil Coelho.

• Tangent Medical Technologies

  Led · Debt Financing · Feb 2014

  Tangent Medical develops and commercializes IV catheters and related products, including the NovaCath™ Integrated IV Catheter System. The NovaCath is a patented, closed safety IV that combines advanced catheter stabilization, passive needle encapsulation and next‑generation tubing management on every start. The company is commercializing its first product and is using external financing to support those commercialization and development efforts. Management says the product was designed after extensive clinical research into the needs of healthcare workers and patients, and that the technology is establishing a new standard in catheter design and performance. Tangent positioned the financing to provide flexibility as it scales commercialization. Tangent Medical Technologies, incorporated in 2010 as a University of Michigan Medical Innovation Center spinoff in Ann Arbor, develops the NovaCath closed-system peripheral intravenous catheter. The company redesigned the peripheral IV system to improve securement and patient comfort, prevent blood splatters and avoid patient exposure to pathogens. The NovaCath won FDA clearance in September, and the company has said the device would hit the U.S. market late this year. Tangent has raised $8.6 million in an equity offering this month from nine investors, according to an SEC filing. Earlier it closed a $4.5 million Series A from Arboretum Ventures, Flagship Ventures, Osage Ventures and several angel investors, and last year hired CEO Jeff Williams, who previously led three medical-related companies through exits. The article also notes the company planned to introduce the product outside the U.S. in 2013. Tangent Medical Technologies is a development-stage medical device company founded in Ann Arbor in 2009 based on technology licensed from the University of Michigan’s Medical Innovation Center. Its lead product is the NovaCath™ Closed IV Catheter System, a peripheral IV (PIV) catheter system designed to reduce common problems with current PIV catheters and improve healthcare worker safety and patient comfort. The NovaCath system was conceived by Tangent’s technical founders Adrienne Harris, Elyse Kemmerer and Steven White, who remain with the company; Jeff Williams is Chairman & CEO. Tangent plans to use the Series A proceeds for regulatory filings and the commercial launch of NovaCath and expects to begin generating commercial revenues in 2012. NovaCath has not received U.S. FDA clearance or other marketing approval as of the announcement. The company cites a large addressable market, noting more than 334 million PIV catheters are sold in the U.S. annually, and reports high dissatisfaction with current products among healthcare workers and patients.

• InfraReDx

  Led · Debt Financing · Nov 2013

  Infraredx, based in Burlington, MA, develops the TVC Imaging System, an intravascular imaging platform that provides simultaneous structural and compositional vessel data in a single pullback. The company positions its technology to improve the safety and efficacy of coronary stenting and to support strategies aimed at preventing initial coronary events. Infraredx supplies practitioners with enhanced information for clinical decision making in treating coronary artery disease. To support its commercialization efforts, GE Capital amended Infraredx’s existing senior secured credit facility, increasing available capital. The amendment converted a $6.6 million senior secured facility into a $20 million facility by adding a $13.4 million multi-draw term loan. GE Capital, Healthcare Financial Services is acting as administrative agent for the credit facility. Infraredx makes the TVC Imaging System, a first-in-class intravascular imaging system that combines near-infrared spectroscopy (NIRS) lipid-core plaque detection with enhanced intravascular ultrasound (IVUS) to assess vessel composition and structure. The device provides true vessel characterization by delivering simultaneous structural and compositional imaging in a single pullback and is the only multimodality system available in the U.S. and Europe for lipid-core plaque detection. Infraredx plans to commercialize the TVC Imaging System in Japan through an exclusive distribution agreement with Nipro Corporation and expects Japanese regulatory approval in the first half of 2014. Proceeds from the recent financing will support the company’s expansion, operations and the Japan commercialization effort. Concurrent with the equity investment, Infraredx increased its term funding arrangement with GE Capital and a Nipro management team member will join Infraredx’s board. Founded in 1998 and headquartered in Burlington, Mass., Infraredx positions its technology to improve clinical decision making in coronary artery disease and to reduce complications during stenting. InfraReDx develops intelligent intravascular imaging technologies aimed at improving diagnosis and treatment of coronary and other vascular diseases. Its flagship product, the TVC Imaging System, is a first-in-class intravascular imaging platform that combines intravascular ultrasound (IVUS) and near-infrared spectroscopy (NIRS) in a single multimodality device. The TVC Imaging System is the only device cleared by the U.S. Food and Drug Administration for the detection of lipid core plaques of interest. The company intends to advance product commercialization efforts supported by recent financing. InfraReDx is based in Burlington, MA. Company leadership noted prior work with GE Capital and said the financing was structured to match its immediate and longer-term growth objectives. InfraReDx is a privately funded medical device company developing and commercializing intelligent cardiovascular diagnostic imaging technologies; it was founded in 1998 and is headquartered in Burlington, Massachusetts. Its core product is the LipiScan IVUS Coronary Imaging System, the first catheter to combine intravascular ultrasound (IVUS) and near-infrared (NIR) spectroscopy to detect and characterize lipid core coronary plaques. The system produces standard IVUS images and a Chemogram™ map in a single catheter pullback, indicating plaque location and quantifying lipid core burden to assist interventional cardiologists. InfraReDx received FDA approval and launched LipiScan in September 2010; the device is being utilized in a growing number of U.S. cardiac centers. The company plans to expand manufacturing operations and commercial infrastructure to meet accelerating physician demand and to support ongoing and new clinical trials investigating expanded clinical applications. The recent financing will fund commercialization expansion and further clinical studies to explore additional uses and benefits of the LipiScan system. InfraReDx is a Burlington, Massachusetts-based medical device company developing intelligent cardiovascular diagnostic imaging technologies. Its core product is the LipiScan™ IVUS Coronary Imaging System, a catheter that combines near-infrared spectroscopy (NIR) and intravascular ultrasound (IVUS). The device is designed to visualize and characterize intracoronary lipid core plaques (LCP) suspected of causing the majority of heart attacks. InfraReDx completed a $21M equity financing. The proceeds will support the full commercial launch of the LipiScan system.

No current team members are available.